Use of Protocol 5.0 will begin Monday, October 17, 2016.

  • Centers that are exempt from Institutional Review Board/Ethics Board (IRB/EB) review should follow their own institution’s policies for implementing Protocol 5.0.
  • Centers that require Institutional Review Board or Ethics Board approval must provide documentation of IRB/EB approval notice prior to Monday, October 17, 2016 in order to access the web based data entry system.

New documents include:
  • Protocol 5.0
  • Manual of Operations and Procedures 5.0
  • Record of Revisions
  • List of New Elements Added with the Implementation of Protocol 5.0
  • Stroke Scale Instructions
  • National Institutes of Health Stroke Scale Questionnaire

The remainder of forms have not had content revisions but contain the updated version number and date.

Manual of Operations

Protocol 5.0

Appendicies


The Intermacs Regulatory Team is available to assist with any questions you may have.

Intermacs / Pedimacs Quarterly Center Reports and Datasets
NEW ADDITIONS

The 2016 Quarter 1 Intermacs / Pedimacs Quarterly Center Reports will be uploaded to the Intermacs / Pedimacs Web Based Data Entry Systems (WBDE) the week of June 27, 2016. Site Administrators at centers with an “Active” status will be able to download these materials directly from the WBDE by clicking on the “File Delivery” page. Please share these reports with your site PI and VAD teams.

New Reports:
  • Intermacs “Recent Year” Quality Assurance Report – In addition to the standard quarterly quality assurance report Intermacs has added a new report limited to patients implanted since the beginning of the last complete calendar year (January 1st, 2015). We hope this comparison using a contemporary cohort will facilitate tracking changes in patient population and outcomes at your site.

  • Pedimacs Federal Partners Report - Intermacs is posting the new Pedimacs Federal Partners Report on the Intermacs website (www.intermacs.org/reports/public-statistical-reports). This report contains an overview of Pedimacs patient characteristics and outcomes for the entire registry.

For questions regarding reports please contact Maceo Cleggett (maceocleggett@uabmc.edu). For questions regarding site datasets please contact John Pennington (johnpennington@uabmc.edu).


Quarterly Report Distribution Schedule

Intermacs quarterly reports are distributed each quarter through the Web-Based Data Entry (WBDE) file delivery system. Reports are distributed three months after coverage stop date to allow complete data entry, data processing, and accuracy checks. Please send any questions and comments to Maceo Cleggett at mclegg@uab.edu.

 Calendar Quarter  Coverage Stop Date  Distribution Date
 Q1  March 31st  June 30th
 Q2  June 30th  September 30th
 Q3  September 30th  December 31st
 Q4  December 31st  March 31st



Transfer Process

If a patient transfers his/her care, the last date of medical contact should be used as the transfer date.  This could be either a date of the last clinic visit, hospitalization or phone call.



Please update your Apple IOS version of Duo Security from your current version to version 3.5.1. The update is available on the Apple iTunes store (Link Below)
This update will fix the protection of the Duo Mobile Security application.
https://itunes.apple.com/us/app/duo-mobile/id422663827?mt=8



Intermacs is sensitive to site and participant confidentiality. Please use a secure e-mail to communicate confidential information with Intermacs staff.  If you do not have a secure e-mail available, contact us at intermacs@uab.edu and request access to the Intermacs secure e-mail.

This project has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract Number HHSN268201100025C.